Anthelios SX Includes an Active Ingredient Previously Unmarketed in U.S.

FDA OKs New Sunscreen

July 24, 2006 -- There's a new over-the-counter sunscreen on the market, and it includes an active ingredient that's new to the U.S.

The FDA today approved Anthelios SX, made by L'Oreal, to prevent sunburn and protect against ultraviolet B (UVB) and ultraviolet A (UVA) rays. The new product has a sun protection factor (SPF) of 15.

Anthelios SX contains a mix of three active ingredients, one of which is ecamsule. Ecamsule has not been marketed in the U.S., but it's been marketed in Europe and Canada as Mexoryl SX since 1993.

Mexoryl SX is "particularly effective against short UVA waves" and doesn't degrade when exposed to the sun for long periods of time, unlike other UVA filters, says a L'Oreal news release.

The new sunscreen's two other active ingredients are avobenzone and octocrylene. Those ingredients are "generally recognized as safe and effective," says an FDA news release.

In 28 studies of Anthelios SX that included more than 2,500 patients, side effects were rare and mild. The most common side effects in patients were acne, dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort, and sunburn, according to the FDA.

"Sunscreens are an important part of total sun protection strategy as consumers arm themselves against the harmful sun rays," says Steven Galson, MD, MPH, in an FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.

However, sunscreens aren't the only way to curb skin damage from the sun.

"While this product provides protection from harmful UVA and UVB rays, the FDA continues to recommend that in addition to using a sunscreen, consumers protect themselves from sun exposure by limiting time in the sun and wearing protective clothing," Galson says.

L'Oreal will sell Anthelios SX, a daily moisturizing cream with sunscreen, as its first product containing Mexoryl SX. The cream will be sold under L'Oreal's La Roche-Posay brand starting this fall in select pharmacies and drugstores, as well as in doctors' offices, according to L'Oreal's web site.